MAUDE Adverse Event Report: SYMMETRY SURGICAL, LLC SYMMETRY SURGICAL; MONOPOLAR ELECTRODE

Model Number	90-4012
Health Effect - Clinical Code	Burn, Thermal (2530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of the incident is unknown.The product has been returned and is being sent to the manufacturing location for further investigation.The customer has been asked multiple times for additional information regarding the patient involvement and usage of the device.There has been a total of (b)(4) sold with no additional complaints recorded for this occurrence.A follow up report will be submitted once we received additional information from the customer or the investigation of the product has been completed.
Event or Problem Description
During a procedure the monopolar electrode burnt the patient's liver.
Additional Manufacturer Narrative
The returned devices were returned to the end manufacturing location for a more in depth review.4 devices were returned for more evaluation.It was determined that 3 out of the 4 instruments showed signs of deterioration and should not of been used during the procedure.The tips of the three devices have exposed metal peeking through the insulation on the end of the tube.This type of early deterioration can be attributed to usage outside of the usage conditions outlined in the ifu.The device history check revealed that there were no abnormalities for this instrument/batch.Possible causes of the instrument deterioration can be contributed to the following.To high power settings and or too long switch-on times during applications.The user not only touches the tissue with the metallic tip, but also touches the tissue with the insulated parts of the instrument during procedure and/or immerses the instrument to a significant extenct in the tissue itself which causes moisture on the outside and inside of the electrode.Based on the examination of the instrument, there is no indication that either the design, material or manufacturing process, or any other circumstance within our influence has given cause for corrrective or preventative actions to be taken.The customer advised the patient has recovered, therefore there were no long lasting affects of the burn caused.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions, a follow up report will be submitted.

• Brand Name: SYMMETRY SURGICAL
• Common Device Name: MONOPOLAR ELECTRODE
• Manufacturer (Section D): SYMMETRY SURGICAL, LLC; 3034 owen drive; antioch, tn
• MDR Report Key: 10411384
• Report Number: 3007208013-2020-00021
• Device Sequence Number: 3220124
• Product Code: GEI
• UDI-Device Identifier: 00887482129708
• UDI-Public: 00887482129708
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040855
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 90-4012
• Device Catalogue Number: 90-4012
• Device Lot Number: E1219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention